Status:
COMPLETED
Topical Antisepsis in Head and Neck Cancer Surgery
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This is a single-arm prospective trial of an intra- and postoperative topical antiseptic bundle. The study will recruit patients undergoing an open surgical resection of the upper aerodigestive tract ...
Detailed Description
The study design is a single-arm prospective trial. It will investigate the microbial effects of topical antisepsis on upper aerodigestive tract and reconstructive surgery in head and neck cancer pati...
Eligibility Criteria
Inclusion
- Age 18 years or older.
- Planned to undergo an open surgical procedure requiring a communication between the upper aerodigestive tract and cervical skin with a planned vascularized reconstruction, which may be either a regional pedicled and/or free flap.
- Subsites reconstructed must include at least one of the following: oral cavity, oropharynx, larynx, hypopharynx, and/or cervical esophagus.
- Eligible patients must be undergoing surgery related to treatment for head and neck cancer. This includes immediate reconstruction after tumor ablation as well as reconstruction for delayed cancer-related indications including radionecrosis or improvement in functional outcomes after head and neck cancer treatment.
- Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Exclusion
- True allergy to any study-related medications
- Active infection at the time of surgery
- Pregnancy or actively breastfeeding mothers. Female subjects who are both lactating and breastfeeding or of childbearing potential who have a positive serum test during screening.
- Patients incarcerated in state or federal penitentiaries
- Patients with a serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Key Trial Info
Start Date :
January 6 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 4 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04721626
Start Date
January 6 2021
End Date
October 4 2021
Last Update
February 7 2022
Active Locations (1)
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1
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226